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Low-Dose Acitretin for Psoriasis
Study Summary
This trial is looking at whether a lower dose of acitretin, a drug used to treat psoriasis, is as effective as the standard dose, but causes fewer side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't used topical vitamin A, D, or similar creams in the last 2 weeks.I agree to use two forms of birth control.I have been on a stable light therapy plan for 4 weeks.I haven't taken any immune system suppressing drugs in the last 4 weeks.I have not used any experimental drugs or treatments in the last 4 weeks.I am a woman who could become pregnant.I am 18 years old or older.I have not had a major illness in the last 30 days.I understand the study and agree to participate by signing the consent form.I am taking 25 mg of acitretin daily and having side effects that may improve with a lower dose.I am not on medication that could interfere with the study.I can follow the study's requirements and complete it.I have used over-the-counter drugs or herbal remedies within the last 2 weeks.I will not drink alcohol while on acitretin and for 2 months after stopping it.You have a weakened immune system.You have a history of or are currently misusing alcohol or drugs.I am a woman who cannot become pregnant due to surgery or menopause.My liver function is severely impaired, more than three times the normal limit.You have uncontrolled high levels of triglycerides in your blood.My psoriasis is guttate, erythrodermic, or pustular.
- Group 1: Low dose Acitretin (17.5 mg)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research constitute a pioneering effort?
"Presently, 4 trials concerning this medication are running across 2 cities and 3 nations. In 2010, Stiefel - a GSK Company – conducted the first investigation with 20 participants which achieved Phase 4 of pharmaceutical authorisation. Since then, 10 more research initiatives have been completed."
Has this medication obtained governmental endorsement?
"The perceived safety of this intervention is rated a 3, as it has been approved for use in Phase 4 trials."
Have there been any other investigations involving this therapeutic approach?
"Presently, 4 clinical trials are underway for this medication. None of the studies have entered into Phase 3 yet and these assessments primarily take place in Hangzhou, Zhejiang; however, there are other sites running tests as well."
Is there an ongoing call for participants to join this clinical trial?
"This trial is no longer seeking participants. It was first published on October 1st, 2010 and the latest update was June 21st 2011. However, there are still 167 trials currently enrolling patients with psoriasis and another 4 studies actively searching for individuals to participate in this particular treatment."
How many participants are currently enrolled in this medical experiment?
"Unfortunately, this experiment is no longer recruiting. The trial was inaugurated on October 1st 2010 and the latest update came out June 21st 2011. However, if you are looking for other studies related to psoriasis there are presently 167 clinical trials actively enrolling participants and 4 trials specifically researching this treatment that need patients."
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